What are the responsibilities and job description for the Senior Quality Engineer position at Indotronix Avani Group?
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As a Sr. Quality Engineer, you will have responsibility for coordinating the Client Quality CAPA portfolio. Coordination includes partnering with those team members to define, investigate, implement, and resolve product and quality systems issues to ensure they don't recur. This position will be responsible for additional Quality Management System project work as needed.
Must Have (Minimum Requirements)
- To be considered for this role, please ensure the minimum requirements are evident on your resume.
- Bachelor’s degree in an engineering field is required
- Minimum of 7 years of CAPA/Quality experience
- Trackwise QMS system experience
- Experience in medical device, pharmaceutical and/or a comparable regulated environment.
- Experience working with non-conformances, corrective and preventive actions, and field actions.
- Understanding of FDA regulations (21 CFR 820, 210/211 as applicable and Part 11), ISO 13485, and quality requirements.
Nice To Have (Preferred Qualifications)
- Experience owning CAPAs which conducted effective root cause investigation, corrective and preventive action planning and execution and verification of effectiveness techniques.
- Strong analytical, process improvement, critical thinking, and decision-making skills.
- Ability to create a CAPA gold standard for the CAPA program.
- Influence management skills: ability to work constructively across all functions of the organization as well as external customers.
- Project management skills.
- Experience reviewing technical documentation.
- Strong written and verbal communication skills.
- Experience with internal and external audits.
- Experience with FDA warning letters and/or consent decrees.